Quick Facts at a Glance
- Recall Date
- December 22, 2025
- Hazard Level
- HIGH
- Brands
- STERILE WATER, Baxter Healthcare Corporation
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- STERILE WATER, Baxter Healthcare Corporation
- Product type
- Sterile Water for Irrigation
- Model numbers
- Lot #: G171359, expiry: 05/31/2027
- UPC codes
- 0338-0003, 0338-0004, 0338-0003-44, 0338-0003-46, 0338-0003-47, 0338-0004-02, 0338-0004-03, 0338-0004-04 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 22, 2025
Reported by FDA DRUG
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Baxter Healthcare Corporation or your healthcare provider for guidance. Notification method: Letter
About This Product
Sterile Water for Irrigation is commonly used in medical settings for irrigation during surgical procedures or wound care. Consumers purchase it for its purity and sterility to ensure safe medical use.
Why This Is Dangerous
The contamination arises from plastic particles that may enter the solution from the bottle rim, presenting a risk if used in medical applications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant quantity of sterile water, potentially disrupting medical procedures and requiring immediate action from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Locate the lot number on the bottle.
- Check if the lot number is G171359.
- Verify the expiration date, which should be before 05/31/2027.
Where to find product info
The lot number and expiration date are typically printed on the label of the bottle.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document your communication with Baxter Healthcare Corporation.
- Consider filing a complaint with the FDA.
- Reach out to consumer protection agencies for assistance.
How to prevent similar issues
- When purchasing medical products, check for recent recalls.
- Verify that products are from reputable manufacturers with good safety records.
- Look for third-party safety certifications.
Documentation advice
Keep copies of any receipts, emails, and records of phone calls related to the product and recall.
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Product Details
The recall affects Sterile Water for Irrigation, 250 mL, packaged in a single-dose plastic bottle. The affected lot number is G171359, with an expiration date of 05/31/2027. The product was distributed nationwide.
Key Facts
- Recall date: December 22, 2025
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Safety Guide
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